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Clinical Trials/NCT01091584
NCT01091584
Completed
Not Applicable

A Randomized Trial to Assess the (Cost) Effectiveness of the Use of the Distress Thermometer by a Nurse in Addition to Usual Care for Patients Treated With Curative Intent for Breast Cancer.

Radboud University Medical Center1 site in 1 country193 target enrollmentMarch 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Patients
Sponsor
Radboud University Medical Center
Enrollment
193
Locations
1
Primary Endpoint
Subscale quality of life of the questionnaire: EORTC QLQ C30
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The use of interventions for cancer-related distress is important to reduce this distress. Distress has a negative impact on quality of life, the recovery during and after treatment and may even adversely affect survival. There is insufficient attention to the systematic approach to psychosocial problems in cancer patients in the Netherlands. A task force discussed and studied which instrument measures psychosocial problems best. The distress thermometer ("lastmeter") had the best results. A guideline is written to use the distress thermometer for patients with cancer and will be used in hospitals in the Netherlands. However, it is not clear what the effects are of the use of the distress thermometer on the psychosocial wellbeing of the patient. Furthermore, it is also unknown whether the use of the distress thermometer leads to cost-effective care. The study focuses on the use of the distress thermometer in breast cancer patients. An efficiency study (RCT) will be conducted to evaluate the systematic use of the distress thermometer and its discussion by a nurse as compared to the usual care provided to outpatients who are treated with curative intent for breast cancer by their treating physicians. The clinical and economic impact of the use of the Distress thermometer will be assessed in comparison with usual care.The recruitment of patients will take place in the out-patient clinic of a university hospital. Patients will be followed from diagnose until two years after finishing their treatment.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
July 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Histologically proven malignancy of the breast
  • Curative treatment
  • Dominated the dutch language
  • Age \> 18 year

Exclusion Criteria

  • Previously treated for a malignancy
  • Psychiatric problems that adherence this study

Outcomes

Primary Outcomes

Subscale quality of life of the questionnaire: EORTC QLQ C30

Time Frame: After each treatment completion, during follow up; first year every 3 months, second year every 6 months

Subscale quality of life of the questionnaire: EORTC QLQ C30

Secondary Outcomes

  • Other subscales(After each treatment completion, during follow up; first year every 3 months, second year every 6 months)

Study Sites (1)

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